FDA product codes

The device classification tree, in product code order.

FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.

Data as of 2026-10-05, the FDA export date. FDA product classification database

Review panels

6,880 codes

FDA review panels and the number of ingested product codes in each
Review panel	Panel code	Product codes
Anesthesiology	AN	262
Cardiovascular	CV	437
Clinical Chemistry	CH	527
Clinical Toxicology	TX	338
Dental	DE	352
Ear, Nose, Throat	EN	269
Gastroenterology, Urology	GU	614
General Hospital	HO	394
General, Plastic Surgery	SU	562
Hematology	HE	281
Immunology	IM	278
Medical Genetics	MG	7
Microbiology	MI	554
Neurology	NE	291
Obstetrics/Gynecology	OB	269
Ophthalmic	OP	345
Orthopedic	OR	349
Pathology	PA	325
Physical Medicine	PM	210
Radiology	RA	216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 33 of 71

FDA product codes, page 33 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
KEL	Adhesive, Albumin-Based	Class I	21 CFR 864.4010	2	0
KEM	Agent, Clearing	Class I	21 CFR 864.4010	15	0
KEO	Formulations, Paraffin, All	Class I	21 CFR 864.4010	11	3
KEP	Media, Mounting, Oil Soluble	Class I	21 CFR 864.4010	3	0
KEQ	Media, Mounting, Water Soluble	Class I	21 CFR 864.4010	7	0
KER	Container, Embedding	Class I	21 CFR 864.3010	5	0
KES	Coverslips, Microscope Slide	Class I	21 CFR 864.3010	3	0
KET	Filters, Cell Collection, Tissue Processing	Class I	21 CFR 864.3010	5	0
KEW	Slides, Microscope	Class I	21 CFR 864.3010	8	1
KEY	Stainer, Tissue, Automated	Class I	21 CFR 864.3800	1	5
KFC	Methylene Blue, Tissue Stain	Class I	21 CFR 864.1850	7	0
KFD	Aniline Blue	Class I	21 CFR 864.1850	1	0
KFE	Neutral Red	Class I	21 CFR 864.1850	1	0
KFF	Assay, Heparin	Class II	21 CFR 864.7525	47	12
KFG	Antiserum, Positive Control, Aspergillus Spp.	Class I	21 CFR 866.3040	5	0
KFH	Antiserum, Positive Control, Blastomyces Dermatitidis	Class II	21 CFR 866.3060	4	0
KFI	Strip, Virulence, Corynebacterium Diphtheriae	Class I	21 CFR 866.3140	0	0
KFJ	Materials, Repair Or Replacement, Pacemaker	Class III	21 CFR 870.3710	3	0
KFK	Saw, Pneumatically Powered	Class I	21 CFR 878.4820	4	1
KFL	Microtome, Sliding	Class I	21 CFR 864.3010	0	0
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Class II	21 CFR 870.4360	84	40
KFT	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical	Class I	21 CFR 890.3420	0	0
KFW	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered	Class I	21 CFR 890.3420	0	0
KFX	Assembly, Thigh/Knee/Shank/Ankle/Foot, External	Class II	21 CFR 890.3500	4	3
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Class I	21 CFR 868.5460	20	3
KGB	Mask, Oxygen, Non-Rebreathing	Class I	21 CFR 868.5570	13	8
KGC	Tube, Gastro-Enterostomy	Class II	21 CFR 876.5980	26	25
KGD	Scissors For Cystoscope	Class II	21 CFR 876.1500	2	0
KGE	Forceps, Biopsy, Electric	Class II	21 CFR 876.4300	46	0
KGF	Adhesive, Tissue For Aneurysmorrhaphy	Class III		1	0
KGG	Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations	Class III		0	2
KGH	Unit, Wrist, External Limb Component, Powered	Class I	21 CFR 890.3420	0	0
KGI	Densitometer, Bone	Class II	21 CFR 892.1170	148	26
KGK	Gas, Collecting Vessel	Class I	21 CFR 868.1575	2	0
KGL	Cabinet, Phototherapy (Puva)	Class II	21 CFR 878.4630	8	0
KGM	Silicone, Liquid, Injectable	Class III		0	0
KGN	Wound Dressing With Animal-Derived Material(S)	Unclassified		192	23
KGO	Surgeon'S Gloves	Class I	21 CFR 878.4460	560	44
KGQ	Cream, Gloving, Surgeon'S	Class I	21 CFR 878.4470	1	0
KGS	Retention Device, Suture	Class I	21 CFR 878.4930	20	2
KGT	Drape, Adhesive, Aerosol	Class I	21 CFR 878.4380	1	1
KGW	Ring (Wound Protector), Drape Retention, Internal	Class II	21 CFR 878.4370	9	0
KGX	Tape And Bandage, Adhesive	Class I	21 CFR 880.5240	187	48
KGY	Bag, Intestine	Class I	21 CFR 878.4100	6	1
KGZ	Accessories, Catheter	Class I	21 CFR 878.4200	29	23
KHA	Mask, Scavenging	Class I	21 CFR 868.5590	1	0
KHE	Reagent, Occult Blood	Class II	21 CFR 864.6550	97	19
KHF	Adenine Nucleotide Quantitation	Class I	21 CFR 864.7040	0	0
KHG	Whole Blood Hemoglobin Determination	Class II	21 CFR 864.7500	39	1
KHH	Stimulator, Caloric-Air	Class I	21 CFR 874.1800	7	0
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Class II	21 CFR 874.3620	34	2
KHL	Hearing Aid, Master	Class II	21 CFR 874.3330	7	0
KHM	Nephelometric, Amylase	Class II	21 CFR 862.1070	6	0
KHO	Fluorometer, For Clinical Use	Class I	21 CFR 862.2560	38	32
KHP	Acid, Lactic, Enzymatic Method	Class I	21 CFR 862.1450	27	19
KHQ	Radioassay, Triiodothyronine Uptake	Class II	21 CFR 862.1715	93	1
KHR	Absorber, Saliva, Paper	Class I	21 CFR 872.6050	10	0
KHS	Enzymatic, Carbon-Dioxide	Class II	21 CFR 862.1160	86	7
KHT	Fraction V, Antigen, Antiserum, Control	Class I	21 CFR 866.5370	1	0
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Class II	21 CFR 866.3220	18	0
KHX	Platform, Force-Measuring	Class I	21 CFR 890.1575	15	0
KHY	Cane, Safety Walk	Class I	21 CFR 890.3075	0	1
KIA	Cover, Cast	Class I	21 CFR 880.6185	1	0
KIC	Cushion, Flotation	Class I	21 CFR 890.3175	29	1
KID	Restraint, Wheelchair, Non-Protective	Class I	21 CFR 890.3910	7	0
KIE	Apparatus, High Pressure Liquid Chromatography	Class I	21 CFR 862.2260	25	2
KIF	Resin, Root Canal Filling	Class II	21 CFR 872.3820	147	2
KIG	Prosthesis, Wrist, Constrained, Polymer	Class II	21 CFR 888.3780	0	0
KIH	Dispenser, Cement	Class I	21 CFR 888.4200	11	5
KII	Tube, Cement Ventilation	Class I	21 CFR 888.4230	0	0
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	Class I	21 CFR 878.4820	29	10
KIK	Hook, Bone	Class I	21 CFR 878.4800	1	0
KIL	Positioner, Socket	Class I	21 CFR 888.4540	1	0
KIM	Device For Sealing Microsections	Class I	21 CFR 864.3400	1	1
KIN	Slide Stainer, Contact Type	Class I	21 CFR 864.3800	1	0
KIO	Slide Stainer, Immersion Type	Class I	21 CFR 864.3800	1	0
KIP	Formulations, Balanced Salt Solutions	Class I	21 CFR 864.2875	17	0
KIQ	Kit, Culture, Chromosome	Class I	21 CFR 864.2260	1	0
KIR	Cells, Animal And Human, Cultured	Class I	21 CFR 864.2280	170	1
KIS	Sera, Animal And Human	Class I	21 CFR 864.2800	45	1
KIT	Media And Components, Synthetic Cell And Tissue Culture	Class I	21 CFR 864.2220	367	4
KIW	Kit, Mycoplasma Detection	Class I	21 CFR 864.2360	2	0
KIX	Media, Mycoplasma Detection	Class I	21 CFR 864.2360	0	0
KIY	Chamber, Slide Culture	Class I	21 CFR 864.2240	1	0
KIZ	Dish, Tissue Culture	Class I	21 CFR 864.2240	8	0
KJA	Flask, Tissue Culture	Class I	21 CFR 864.2240	13	1
KJB	Apparatus, Roller	Class I	21 CFR 864.2240	3	0
KJC	Bottle, Roller, Tissue Culture	Class I	21 CFR 864.2240	3	0
KJD	Spinner, Flask	Class I	21 CFR 864.2240	0	0
KJE	Spinner System, Cell Culture	Class I	21 CFR 864.2240	0	0
KJF	System, Suspension, Cell Culture	Class I	21 CFR 864.2240	4	0
KJG	Tube, Tissue Culture	Class I	21 CFR 864.3010	1	1
KJH	Apparatus, Perfusion	Class I	21 CFR 864.2240	3	0
KJI	Radioimmunoassay, Kanamycin	Class II	21 CFR 862.3520	6	0
KJJ	Cleanser, Root Canal	Unclassified		41	7
KJK	Auramine O	Class I	21 CFR 864.1850	2	0
KJL	Azure C	Class I	21 CFR 864.1850	0	0
KJM	Bismarck Brown Y	Class I	21 CFR 864.1850	0	0
KJN	Brilliant Cresyl Blue	Class I	21 CFR 864.1850	1	0
KJO	Brilliant Green	Class I	21 CFR 864.1850	0	0